Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management

Sponsor

Dermatology & Aesthetics of Wicker Park (Other)

Overall Status

Completed

CT.gov ID

NCT01660217

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized controlled study. The control group will consist of adult subjects and the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis (AD), who are visiting a dermatologist for a standard AD office visit. In the control group, only verbal instruction (VI), the standard of care, will be provided. The intervention group will receive a similar VI with an additional component: an eczema education handout, as well as an individualized written Eczema Action Plan (EAP) that will illustrate how to recognize disease flare-ups and subsequent remissions. In addition, the EAP will provide detailed step-wise instructions regarding treatment modifications for the above-mentioned variations in treatment severity. To ensure that all patients ultimately receive the same level of care, the control group will also receive an EAP at the end of their consultation.

The goal of this study is to assess subjects' perception in the provider's use of an EAP and its effectiveness in helping patients understand their disease and management plan. In order to evaluate the primary end-points, subjects in both the control and treatment groups will be asked to complete post-consultation surveys. Four post-consultation outcomes will be measured: (1) caregivers' understanding of the disease and treatment, (2) caregivers' comfort level in following the EAP at home, (3) caregivers' anxiety level in managing the AD at home, and (4) caregivers' preference for VI + EAP as compared to VI alone, EAP alone, or neither the EAP nor the VI.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Other: A written Eczema Action Plan (EAP)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Initial Verbal Instruction Group The group who initially received only verbal instruction, and then later (in the "crossover portion") received a written Eczema Action Plan (EAP)	Other: A written Eczema Action Plan (EAP) A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.
Experimental: Written Eczema Action Plan (EAP) The group given a written EAP after verbal instruction	Other: A written Eczema Action Plan (EAP) A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.

Arm

Intervention/Treatment

Experimental: Initial Verbal Instruction Group

The group who initially received only verbal instruction, and then later (in the "crossover portion") received a written Eczema Action Plan (EAP)

Other: A written Eczema Action Plan (EAP)

A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.

Experimental: Written Eczema Action Plan (EAP)

The group given a written EAP after verbal instruction

Other: A written Eczema Action Plan (EAP)

A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.

Outcome Measures

Primary Outcome Measures

Participants understanding of atopic dermatitis and homecare regimen [At the beginning of the visit and at the end of the visit (approximately 45min later)]

Secondary Outcome Measures

Changes in emotional distress level on disease self-management [At the beginning of the visit and at the end of the visit (approximately 45min later)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 or older fulfilling Hanifin and Rajka diagnostic criteria for AD, or adult caregivers for patients younger than 18 years of age, and the ability to comprehend study materials in English